FDAnews Device Daily Bulletin

FDA Urged to Examine BPA in Medical Devices

June 26, 2008
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Rep. Rosa DeLauro (D-Conn.) is urging the FDA’s Science Board to expand its inquiry of bisphenol A (BPA) to include medical devices.

DeLauro also calls on the board to identify all medical devices containing BPA — as Health Canada has done.

“Scientific studies have linked BPA to neurological and behavioral problems in youngsters, as well as certain cancers, diabetes and obesity,” DeLauro says in a letter to Frank Torti, the principal deputy commissioner and chief scientist at the FDA.

Earlier this month, Torti asked the Science Board to establish a subcommittee to assess BPA, a chemical used in some plastic baby bottles, food containers and water bottles.

The subcommittee will hold a public meeting on the safety of BPA in plastics, review an agency task force report on the chemical and present its findings at the Science Board’s annual meeting this fall, the FDA has said.

In April, the FDA formed an agency task force to review information on BPA. The team is creating an inventory of regulated products that contain the chemical and is researching its safety in those products, Torti said. After the review, the task force will make recommendations to the FDA commissioner on what steps to take next.

DeLauro says a review of bottles and food containers falls short. “The potential risks posed to patients by BPA leaching from medical devices, especially implantable ones, would be very significant,” her letter says. “I strongly urge you to expand your request, and have the Science Board also assess the safety of BPA in medical devices.”